3 ms·
Even if they abandon PIII, FDA needs efficacy data. So, these companies would stop running underpowered PII trials. Then companies can't use posthoc analysis fr
by raincom 10y ago
Even if they abandon PIII, FDA needs efficacy data. So, these companies would stop running underpowered PII trials. Then companies can't use posthoc analysis from PII to submit NDA. So, they need to run another PII with biomarkers identified in the posthoc analysis. There are lots of nanocap biotechs running scams just to advance to PIII after showing minimal efficacy in PII; these companies' execs just wanna milk huge salaries as long as the trials go on.